Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-974-4 | CAS number: 101-77-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Animal data on skin sensitization do not result in conclusive evidence on the skin sensitization potential of MDA. However, based on the data on humans there is convincing evidence that MDA is a skin sensitizer. MDA also demonstrates cross-reactions to para-groups. Based on human data MDA is already classified as "sensitising". (From the EU Risk assessment on MDA published 2001)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Lintine discs having a diameter of 1 1/4 inches were saturated with methylene dianiline dissolved in Dowanol 50B. The patches were applied every other day for 15 applications to the skin of the fifty subjects. Results were graded and recorded upon removal of the patches. Twenty-four hours after removal of the patches, the sites were examined for delayed reactions. The material was originally patched as a 5% solution in Dowanol 50B. After the second application, the concentration was reduced to 2 1/2%. Following the fourth application, the concentration was further reduced to 1% in 50B for the remaining number of applications. Following a two week recuperation period after the removal of the fifteenth application, the methylene dianiline as a 1% solution in Dowanol 50B was re-applied for twenty-four hours. Results were graded and recorded upon removal of the patches. Twenty-four hours after removal, the sites were examined for delayed reactions.
- GLP compliance:
- no
- Remarks:
- prior to GLP
- Type of study:
- other: Human Repeated Insult Patch test
- Justification for non-LLNA method:
- This study was conducted due to non-REACH regulatory requirements. With the existing data from this study not only being acceptable but of good quality (Klimisch Score 2), this study precludes the need for an additional LLNA study. In addition, a supplementary LLNA study would violate the ECHA objectives with regards to animal welfare.
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: R. L. Titus, K1937-5 (Ref.: Bi/38; Bi/809) - Species:
- human
- Sex:
- male/female
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Dowanol 50B
- Concentration / amount:
- 1, 2.5, 5%
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Dowanol 50B
- Concentration / amount:
- 1 %
- Day(s)/duration:
- 14 / 24 hours
- No. of animals per dose:
- 25 of each sex
- Challenge controls:
- vehicle (Dowanol 50B)
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 5
- Total no. in group:
- 50
- Clinical observations:
- 1 male showed a 2+ reaction, 3 male subjects showed a 3+ reaction, and 1 female subject showed a 3+ reaction
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
Reference
The material was found to cause a sensitization reaction in 5 of 50 human subjects patch tested by a repeated insult technique.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
In a guinea pig maximisation test, MDA showed a weak sensitizing potential (Thorgeirsson, 1978). However, patch tests in volunteers revealed a skin sensitizing potential of MDA in man (Dow, 1954). No skin sensitising potential was observed in an available Buehler assay (Dow, 1954).
Lintine discs having a diameter of 1 1/4 inches were saturated with methylene dianiline dissolved in Dowanol 50B (Dow, 1954). The patches were applied every other day for 15 applications to the skin of fifty volunteers. Results were graded and recorded upon removal of the patches. Twenty-four hours after removal of the patches, the sites were examined for delayed reactions. The material was originally patched as a 5% solution in Dowanol 50B. After the second application, the concentration was reduced to 2 1/2%. Following the fourth application, the concentration was further reduced to 1% in 50B for the remaining number of applications. Following a two week recuperation period after the removal of the fifteenth application, the methylene dianiline as a 1% solution in Dowanol 50B was re-applied for twenty-four hours. Results were graded and recorded upon removal of the patches. Twenty-four hours after removal, the sites were examined for delayed reactions.
There were sporadic 1 +, 2 +, or 3+ reactions after induction applications. As a check against the possibility of irritation being elicited by the solvent, separate patches were run with the Dowanol 50B. These patches were all negative.
Upon removal of the challenge application, 1 male showed a 2+ reaction, 3 male subjects showed a 3+ reaction, and 1 female subject showed a 3+ reaction. These reactions were characterized by welts and edema extending well beyond the area of the patch. The reactions following the challenge application indicate that 2 male subjects were sensitized by methylene dianiline. It is believed that 2 male subjects and the female subject, who elicited a response after one or two applications during the induction phase, may have exhibited a cross-sensitization reaction to a similar material. In summary, the results of the skin tests with human subjects show that methylene dianiline is not a primary irritant or a fatiguing agent, but it is capable of causing sensitization.
Thorgeisson et al. conducted a GMPT in accordance with Magnusson and Kligman. The animals (guinea pigs) were sensitized in a two-stage procedure- intradermal injections with Freunds Complete Adjuvant (FCA) and topical application. Two weeks after the second stage of sensitization, a 24-hour occluded patch test (AI-test, Imece, Astra Agency) was performed on the flank without chemical depilation. The challenge site was evaluated 24 hours after removal of the patch. Three hours before reading, the test site was shaved with an electric razor. Only obvious redness and swelling was regarded as an allergic response. The reactions were judged by two persons independently. The test substance produced reactions in 20% of the animals (mild sensitizer).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance needs to be classified and labelled as skin sensitising cat. 1 (H317 may cause allergic skin reaction) under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.